Clinical Trial

A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR) (NVL-655-04)

MOA: NVL-655 is an ALK TKI, designed for broader coverage of ALK resistance mutations, activity in the CNS, and selectivity over TRKB.

Key Eligibility Criteria:

• Histologically or cytologically confirmed LA (not amenable for multimodality treatment) or metastatic NSCLC
• Documented ALK rearrangement in tissue or blood (circulating tumor DNA [ctDNA]) – Local testing
  • Pre-treatment tumor tissue must be submitted for central analysis during screening
• No prior systemic anticancer tx for NSCLC, including but not limited to molecularly targeted agents, angiogenesis inhibitors, immunotherapy, or chemotherapy
  • Adj/neoadjuvant chemotherapy is allowed if completed ≥12 months prior to randomization.
  • Prior ALK TKI as adj/neoadj tx is not permitted
• No other known oncogenic driver alterations other than ALK
• Measurable disease by RECIST 1.1